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Back To Vidyya Study Demonstrates Differences In Blood Pressure And Edema Between Celebrex® And Vioxx®

Head-To-Head Safety Comparison Of COX-2 Specific Inhibitors

Study results presented yesterday at the American College of Cardiology's (ACC) annual meeting showed that elderly hypertensive osteoarthritis (OA) patients taking Vioxx® (rofecoxib) experienced a statistically significant increase (approximately 3 mm Hg) in mean systolic blood pressure compared with those taking Celebrex® (celecoxib capsules). In comparison, Celebrex patients showed no increase in mean systolic blood pressure.

"These data provide a head-to-head safety comparison of the COX-2 specific inhibitors in a clinically relevant patient population: those with osteoarthritis and high blood pressure. This study helps us gain a better assessment of some of the potential differences between Celebrex and Vioxx at the most commonly used doses in clinical practice," said William B. White, MD, professor of medicine and chief, section of hypertension and clinical pharmacology at the University of Connecticut School of Medicine in Farmington. "The data also show a higher proportion of patients lost their hypertension control on Vioxx (17 percent) compared to Celebrex (11 percent)."

The study was a six-week, multi-center, randomized, double-blind, parallel trial of approximately 810 hypertensive OA patients -- all of whom were being treated with anti-hypertensive medication. Participants were age 65 or older, with more than half of patients between the ages of 65 to 74 -- a population that is representative of the majority of OA patients. Patient assessments were conducted at baseline and then at weeks one, two and six to examine key measures of cardiorenal safety such as edema and systolic blood pressure.

This same study and full manuscript will be published in the March 22nd issue of the American Journal of Therapeutics. The study was designed to compare clinically significant incidences of cardiorenal events (blood pressure and edema) associated with Celebrex (200 mg once daily) with that of Vioxx (25 mg once daily). These two doses are the most frequently prescribed doses of both products(1). Data showed that 9.5 percent of Vioxx-treated patients experienced a clinically significant increase in edema compared to 4.9 percent of Celebrex-treated patients (p=0.014). Another study finding showed that at any time during the trial, significantly more patients in the Vioxx arm (17 percent) experienced increases in systolic blood pressure (>20 mm Hg with an absolute value >140 mm Hg; p=0.032) versus those taking Celebrex (11 percent).

"As there is such a high comorbidity of hypertension and arthritis, researchers continue to study the potential relationship between heart-related side effects and arthritis medications," said Andrew Whelton, MD, a nephrologist and adjunct professor of medicine at Johns Hopkins School of Medicine, and lead investigator and author of the published study. "This study provides preliminary evidence that Celebrex and Vioxx may affect elderly hypertensive patients differently, suggesting that not all COX-2 specific inhibitors are the same." Arthritis and hypertension are the first and second most common chronic conditions affecting 50 and 40 percent of adults age 65 years and older respectively(2). An estimated 43 million Americans -- nearly one out of every six people -- suffer from arthritis(3). Of those, approximately 18 million (42 percent) also have hypertension(4).

The most commonly reported (>5 percent) adverse events in the Celebrex group were upper respiratory tract infection (7.1 percent) and dyspepsia (5.1 percent). The most commonly reported adverse events in the Vioxx group were headache (8.5 percent), dyspepsia (7.3 percent), diarrhea (5.5 percent), and abdominal pain (5.0 percent). A total of 37 (9 percent) Celebrex- and 36 (9 percent) Vioxx-treated patients withdrew from the study because of adverse events.

The interaction of the heart and kidneys is vital to overall health. The term "cardiorenal" describes the complex physiologic interactions between the two organs. As the heart pumps blood through the vascular system, the kidney manages important aspects of body chemistry by filtering out unwanted elements of wastes and helping to control blood pressure. As the normal process of aging progresses, blood flow decreases to the kidneys. Similarly, the risk of cardiovascular disease (heart attack, stroke) also increases with age, as does the incidence of arthritis.

In terms of the cardiorenal relationship, the greater the reduction in blood flow to the kidney, the greater the reduction in kidney function. If the kidneys are not functioning properly it can result in salt and water retention (edema). This increase in fluids can elevate blood pressure, causing the heart to work harder and may exacerbate underlying cardiovascular conditions such as hypertension. The impact of increases in systolic blood pressure was discussed in a recent paper published in the April 19th, 2000 issue of The Journal of the American Medical Association (JAMA).(5)

  • 1. IMS Weekly National Prescription Audit, Retail and Mail Order Channels, week ending 5/26/00 (accounting for more than 75% of total prescriptions for each product.)

  • 2. Desai MM, Zhang P, Hennessy CH: Surveillance for morbidity and mortality among older adults _ United Stated, 1995-1996. Morb Mortal Wkly Rep CDC Surveill Summ 1999; 48:7-25.

  • 3. National Arthritis Action Plan: A Public Health Strategy (Arthritis Foundation, CDC).

  • 4. IMS Disease and Therapeutics Index 1999

  • 5. ALLHAT Collaborative Research Group. JAMA 2000;283:1967-75.

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Editor: Susan K. Boyer, RN
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